Compensation quantum, time frame absent in clinical trial rules

The rules notified by the government for compensating clinical trial victims have failed to address the concerns raised by patient groups and health activists. The norms, which have come into place after repeated slamming of the government by the Supreme Court, do not specify any quantum of compensation that pharmaceutical companies must pay to those harmed by clinical trials. Also, it has fallen short of prescribing a time frame within which the compensation should reach the victims.

According to the gazette notification, issued by the ministry of health and family welfare on January 30, in case of death or injury, the sponsor of the clinical trial will be required to pay compensation as recommended by the ethics committee in its report. “In case of serious adverse event of death occurring to the clinical trial subject, the ethics committee shall forward its report on the serious adverse event of death, after due analysis, along with its opinion on the financial compensation, if any, to be paid by the sponsor or his representative…, to the chairman of the expert committee constituted by the Licensing Authority…,” the notification said. “In case of clinical trial related death of the subject, his/her nominee(s) would be entitled for financial compensation, as per the order of the Licencing Authority…, and the financial compensation will be over and above any expense incurred on the medical management of the subject,” it added.

However, health activists question the sanctity of the ethics committee itself. “Many of these ethics committee are not functioning ethically themselves. How can they recommend a compensation?,” questions Mira Shiva of the All India Drugs Action Network, which moved the court against the issue.

An ethics committee is a panel of experts from multiple disciplines, including medical academicians, social work and law, to monitor the rights and wellbeing of patients or subjects participating in a research study. At present, every pharmaceutical company has to seek approval from the Drugs Controller General of India and from an ethics committee before starting any trial, but these panels are often located far from the trial sites.

“Often, the ethics committee is not privy to the situation on the site because it is located at a very distant place. This must be revisited because it does not serve the purpose at all,” says another health expert.

According to the expert, it is also a matter of concern that there is no legal requirement for investigators or members of the ethics committees to declare a conflict of interest. In some cases, it was found that the principal investigator in the trial was also a member of the ethics committee.

While the government has mandated companies to pay compensation in case of death and free medical management in case of injury, the absence of quantum and specific time frame is seen as a major loophole in the implementation of the rules.

According to submissions by the government in Parliament, despite 668 deaths during clinical trials in 2010, compensation was paid only in 22 cases, that, too, mostly as low as Rs 1.5 lakh.